AMG 334 (erenumab) trial success in chronic migraine prevention. Novartis + Amgen

Novartis announced positive first results from the global phase II 20120295 study , investigating the efficacy and safety of the fully human monoclonal antibody AMG 334 (erenumab) in chronic migraine prevention. The study evaluated AMG 334 at two doses, 70mg and 140mg, administered subcutaneously once a month, with both doses meeting the study's primary endpoint of a statistically significant reduction in the number of monthly migraine days versus placebo. Overall, patients had a mean baseline of 18 migraine days per month. Patients randomized to the 70mg and 140mg dose groups experienced a mean 6.6-day reduction from baseline in monthly migraine days in both groups. The results were statistically significant compared with 4.2 days observed in the placebo group.

The safety and tolerability profile of AMG 334 was similar to placebo in both treatment groups. No adverse event was reported in greater than five percent of patients treated with AMG 334; the most commonly reported adverse events included injection site pain, infection of the upper respiratory tract and nausea. Additional analyses of these data are ongoing and are expected to be submitted to a future medical meeting and for publication.